This Blog is created for the updation of knowledge on Quality Assurance, current Good Manufacturing Practices (cGMP) and current Updates from all regulatory authorities. Also one can archive Standard Operating Procedures (SOPs), specification and pharma jobs etc. for any Pharma plant.

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Saturday, November 20, 2010

Instructions for the preparation of Master Formula Record.

1.0Purpose : To provide instructions for the preparation of Master Formula Record.

2.0Objective : To provide a documented procedure for the preparation of Master Formula Record.

Master Formula Record is that standard manufacturing / packing record which gives complete details of materials used along with their quantities, standard process flow, Area & equipment used, Yield and reconciliation, Instruction & precautions or any other information related to product.

3.0 Scope : This procedure is applicable for the preparation of Master Formula Record in QA department at ------ Pharmaceuticals, .

4.0Responsibility :

§Follow up : Officer – QA

§Over all responsibility : Q.A Manager.

5.0Procedure :

·Any Master document prepared relating to the plant must include following: -

ØThe name of the product together with product reference code relating to its specifications.

ØThe proprietary name of the product along with the generic name, strength of the product and batch size.

ØMention-Name, quantity, and reference number of all the starting materials to be used. Also any substance that may ‘disappear’ in the course of processing must be mentioned.

ØThe master document must also contain the statement of the expected final yield with the acceptable limits, and of relevant intermediate yields, where ever applicable.

ØInclude a statement of the processing location and the principal equipment to be used.

ØIt must include the methods or the reference to the methods, to be used for preparing the critical equipment including cleaning, assembling and calibration.

ØDetailed stepwise processing instructions and the time taken for each step must be clearly mentioned.

ØThe instructions for In-process controls with their limits.

ØThe requirements for storage conditions of the products, including the container, labeling and special storage conditions wherever applicable must be mentioned.